A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age50-120
SponsorOntario Clinical Oncology Group (OCOG)
About this trial
The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.
Eligibility criteria
Qualifiers
Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, Appendix II).
Treated by BCS with microscopically clear resection margins >= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and/or biopsy, for women with unifocal tumours <= 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy
Disqualifiers
Age less than 50 years.
Known to be BRCA 1 and/or BRCA 2 positive.
Tumour size >3cm in greatest diameter on pathological examination.
Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are <= 3cm remain eligible
Trial design
Treatments tested in this trial
- Whole Breast Irradiation (WBI)
- Partial Breast Irradiation (PBI)
Treatment groups
910 Participants
are divided into 2 treatment groupsLocations
29Australia
GenesisCare Darlinghurst2010, DarlinghurstNew South Wales, Australia
GenesisCare Hurstville2220, HurstvilleNew South Wales, Australia
GenesisCare Mater Hospital2060, North SydneyNew South Wales, Australia
GenesisCare Bundaberg4670, BundabergQueensland, Australia
Sponsors and collaborators
Ontario Clinical Oncology Group (OCOG)
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov